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Prevention of Falls Among Older Adults in Community Settings

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ClinicalTrials.gov Identifier: NCT02287740
Recruitment Status : Active, not recruiting
First Posted : November 11, 2014
Last Update Posted : August 27, 2019
Sponsor:
Information provided by (Responsible Party):
Oregon Research Institute

Brief Summary:
Objective: To conduct a comparative efficacy and cost-effectiveness study of an evidence-based fall prevention program—Tai Ji Quan: Moving for Better Balance (TJQMBB).

Condition or disease Intervention/treatment Phase
Fall Behavioral: Tai Ji Quan: Moving for Better Balance Behavioral: Multimodal Exercise Behavioral: Stretching Not Applicable

Detailed Description:
To determine the effectiveness and cost-effectiveness of the two evidence-based exercise programs (Multimodal Exercise,TJQMBB) relative to stretching, a proxy for a minimum practice standard, in reducing falls among older adults at risk of falling.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 670 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Comparative Effectiveness and Cost-effectiveness of a Fall Prevention Intervention: Tai Ji Quan: Moving for Better Balance
Study Start Date : November 2014
Actual Primary Completion Date : December 31, 2018
Estimated Study Completion Date : March 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Falls

Arm Intervention/treatment
Experimental: Tai Ji Quan: Moving for Better Balance
This protocol involves training 2 times a week for 6 months.
Behavioral: Tai Ji Quan: Moving for Better Balance
The protocol involves a core 8-form routine training with built-in variations and a subroutine of integrated therapeutic movements.

Active Comparator: Multimodal Exercise
This protocol involves training 2 times a week for 6 months.
Behavioral: Multimodal Exercise
The protocol involves a multi-modality program that involves aerobic, strength, balance, and flexibility exercises.

Sham Comparator: Stretching
This protocol involves participation of 2 times a week for 6 months.
Behavioral: Stretching
The protocol represents a minimum standard of practice for exercises for older adults with activities consisting primarily of seated exercises accompanied by breathing, stretching, and relaxation.




Primary Outcome Measures :
  1. Change in the number of falls [ Time Frame: Baseline, 6 Months ]
    Using a daily diary "fall calendar," falls reported by participants across the 24-week surveillance period will be collected, starting from the date of first intervention class and continuing until participants withdrew, had died or were lost to follow-up.


Secondary Outcome Measures :
  1. Functional Reach [ Time Frame: Baseline, 6 Months ]
    assessing the maximal distance (in inch) participants one can reach forward, beyond arm's length, while maintaining a fixed based of support in the standing position. Differences between baseline and 6 months scores will be calculated to assess change.

  2. Instrumented Timed Up and Go [ Time Frame: Baseline, 6 Months ]
    assessing the time to complete a series of functional tasks (sit-to-stand, 180 degree turn, turn-to-sit.) while walking through a 7-meter walkway (7 meters towards a line, turn, and 7 meters towards the chair). The measure is assessed in second. Differences between baseline and 6 months scores will be calculated to assess change.

  3. Physical Performance [ Time Frame: Baseline, 6 Months ]
    The physical performance measure consists of 4-meter walk at usual pace, a timed repeated chair stand, and 3 increasingly difficult standing balance tests. Each measure is assigned a categorical score ranging from 0 (inability to complete the test) to 4 (best performance). A summary score ranging from 0 (worst performance) to 12 (best performances) will be calculated by summing the 3 components scores.

  4. Cognitive function [ Time Frame: Baseline, 6 Months ]
    Montreal Cognitive Assessment (in points). Differences between baseline and 6 months scores will be calculated to assess change.

  5. Cost per fall prevented [ Time Frame: Baseline, 6 Months ]
    determined by calculating total intervention cost estimates divided by number of falls observed during the 6 month intervention.



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Ages Eligible for Study:   70 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • aged 70 years or older living independently in the community
  • at least one fall in the preceding 12 months and a referral from a healthcare provider indicating the participant is at risk of falls due to gait/balance impairment or medication use or impaired mobility as evidenced by Timed Up and Go result of >13.5 seconds
  • no participation in daily and/or structured vigorous physical activity or walking for exercise that lasted 15 minutes or longer at a time or muscle-strengthening activities on 2 or more days a week in the previous 3 months
  • walking independently, with or without the use of an assistive device,
  • no severe cognitive impairment (Mini-Mental State Examination score ≥20)
  • able to exercise safely as determined by their healthcare provider,
  • a willingness to be randomly assigned to an intervention condition and complete the 6-month intervention and 6 month follow-up.

Exclusion Criteria:

  • any medical or physical conditions deemed unacceptable by their physician or healthcare provider,
  • planned to leave the study area within the next 12 months.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02287740


Locations
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United States, Oregon
Oregon Research Institute
Eugene, Oregon, United States, 97403
Sponsors and Collaborators
Oregon Research Institute
Investigators
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Principal Investigator: Fuzhong Li, Ph.D. Oregon Research Institute

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Oregon Research Institute
ClinicalTrials.gov Identifier: NCT02287740     History of Changes
Other Study ID Numbers: 1R01AG045094-01A1 ( U.S. NIH Grant/Contract )
First Posted: November 11, 2014    Key Record Dates
Last Update Posted: August 27, 2019
Last Verified: August 2019
Keywords provided by Oregon Research Institute:
Exercise